What are the procedures for the issuance of import licenses for medical devices in Vietnam in 2023? What is the application?
What are the procedures for the issuance of import licenses for medical devices in Vietnam in 2023?
Pursuant to the provisions in Section 6 of the administrative procedures promulgated together with the Decision 2962/QD-BYT in 2023 stipulating the procedures for the issuance of import licenses for medical devices in 2023 as follows:
Step 1: The organization applying for an import license shall submit a dossier to the Ministry of Health through the Information System for handling administrative procedures of the Ministry of Health (https://dichvucong.moh.gov.vn) or the e-Portal on medical equipment management (https://dmec.moh.gov.vn/);
Step 2: In case there is no request to amend or supplement the application for a import licenses for medical devices, the Ministry of Health is responsible for:
Organize the appraisal for import license within 15 working days and 02 working days for medical equipment without a free-sale registration number to meet urgent needs of fighting epidemics, overcoming natural consequences, from the date of receipt of a complete and valid application (including a written certification of payment of the fee for assessment and grant of an import license as prescribed by the Ministry of Finance). In case of refusal, there must be a written reply clearly stating the reason.
The import licenses shall be sent to the organization or individual requesting the import and the customs office.
In case the application for import licenses for medical devices is incomplete, the Ministry of Health must notify the organization or individual applying for a import licenses for medical devices to supplement or amend the dossier which must specify which documents to supplement, which contents need to be amended within 10 working days and 02 working days for medical equipment without a free-sale registration number imported to to urgently prevent and control epidemics and overcome consequences of natural disasters, from the date of receipt of complete and valid dossiers.
Step 3: When receiving a written request for addition or modification of the import file, the organization applying for an import license must supplement and amend it according to the contents recorded in the document and send it to the Ministry of Health.
In case the organization or individual applying for an import license has supplemented or modified the dossier but it is not in accordance with the requirements, the Ministry of Health will notify such organization or individual to continue to complete the dossier.
After 30 days from the date the Health Ministry issues a written request, if the organization or individual applying for the import license fails to supplement or amend the dossier, it must start over.
Step 4: If there are no additional requirements or amendments, the Ministry of Health is responsible for granting an import license. Import licenses are sent to the organizations or individuals requesting the import and the customs offices.
What are the procedures for the issuance of import licenses for medical devices in Vietnam in 2023? What is the application?
What is the application for the issuance of import licenses for medical devices in Vietnam?
Pursuant to the provisions in Section 6 of administrative procedures issued together with Decision 2962/QD-BYT in 2023, the application for import licenses for medical devices medical equipment includes:
- A written request for an import license;
- Technical brief documents for medical devices that are reagents, calibrators, in vitro control materials;
- A document describing the technical summary for chemicals and preparations with only one purpose: sterilizing medical equipment;
- Documents describing the types of medical equipment;
- The certificate of satisfaction of quality control standards of that medical equipment manufacturer, certified by the organization or individual applying for the import license;
- In case of import for research purposes, there must be a certified copy of the decision approving the research topic and documents proving that the medical equipment requested for import has been approved by the competent authority, certified by the organization or individual applying for the import license;
- In case of import for training, there must be the original training program and documents proving that the medical equipment requested for import has been approved for circulation by the competent authority, certified by the organizatio, individuals applying for import licenses;
- In case of import for use for inspection, testing, testing and quality assessment purposes, a written certification from the unit competent to carry out the inspection, testing and testing is required, quality rating which states the quantity;
- In case of import for aid, there must be a copy of the decision approving the receipt of aid by the competent authority and documents proving that the medical equipment requested for import has been approved by the competent authority, certified by the organization or individual applying for the import license;
- In case the import is a gift or a gift to a medical facility, there must be a copy of the document showing the content of the donation or donation and the document proving that the medical equipment requested for import has been approved by the competent authority with the certification of the organization or individual applying for the import license;
- In the case of import to serve humanitarian medical examination and treatment activities, there must be additional documents proving that the medical equipment requested for import has been approved for circulation by a competent authority, certified by the competent authority. organizations and individuals applying for import licenses;
- For the case of import for special diagnostic needs of medical establishments, there must be additional documents proving that the medical equipment requested for import has been approved for circulation by the competent authority, certified by the competent authority. organizations and individuals applying for import licenses;
- In case of import for personal medical use, including personal-specific medical equipment, a copy of the written order of a doctor in accordance with the individual's disease is required;
- In case of import for use in trade fairs, exhibitions, display or product introduction, a copy of documents on the program, invitation and performance contract is required;
- For cases of import to meet urgent needs of disease prevention and control, and to overcome consequences of natural disasters, the following documents are required:
+ A written approval from a competent authority for urgent needs in disease prevention and remediation of consequences of natural disasters or catastrophes;
+ Documents proving that the medical equipment to be imported has been approved for circulation or for emergency use by a competent authority, certified by the organization or individual applying for the import license.
- For the case of importing medical equipment without a free-sale registration number imported for use at medical facilities purchased from official development assistance (ODA) capital and concessional loans, aid Non-refundable, not under official development assistance, an application for an import license must include the following additional documents:
+ The original or a certified true copy of the decision approving the investment policy and the decision on investment, for investment projects, or the decision approving project documents, for technical assistance projects and project costs. or a grant that is not part of official development assistance, clearly stating the import of medical equipment;
+ The original or a certified true copy of the contract to provide medical equipment for the project;
+ The power of attorney of the owner of the medical equipment for the organization applying for an import license is still valid at the time of application submission. Submit a consularly legalized copy or a certified copy of the consularly legalized copy;
+ A certificate of eligibility for warranty issued by the owner of the medical equipment, unless the medical equipment is used once as prescribed by the owner of the medical equipment or has documents proving it. no warranty. Submit a consularly legalized copy or a certified copy of the consularly legalized copy;
+ The certificate of free sale is valid at the time of application for imported medical equipment. Submit the consularly legalized copy or a certified copy of the consularly legalized copy. In case the circulation paper is not in English or not in Vietnamese, it must be translated into Vietnamese. The translation must be certified according to the provisions of law.
How long does it take to issue import licenses for medical devices in Vietnam?
Pursuant to the provisions in Section 6 of administrative procedures issued together with Decision 2962/QD-BYT in 2023, the time limit for issuance of import licenses for medical devices is as follows:
15 working days from the date of receipt of the application (including a confirmation that the fee for assessment and grant of an import license has been paid in accordance with regulations of the Ministry of Finance);
02 working days for medical equipment without a free-sale registration number imported to meet urgent needs of disease prevention and control, and to overcome consequences of natural disasters, from the date of receipt of the dossier.
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